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To return to a dispassionate examination of this theme. Drug testing occurs in several stages and Dr Empirical can give a clearer exposition of this than I can. The first stages examine the kinetics of the drug and the pharmacological effects both good and bad. Initial testing with live subjects involve animals preferably those which are known to respond to the drug category in similar ways to humans. When it comes time to test human subjects all experimental protocols are now studied by institutional ethics review committees and a very high standard of disclosure to the potential subject is demanded. Potential risks and benefits must be clearly outlined. Ideally trials should be 'double-blinded' i.e. neither researcher nor subject know whether or not the subject is receiving the tested drug or placebo. Initial human trials are usually on healthy subjects to determine the pharmacokinetics of the drug on humans and the presence of any unforeseen adverse effects. Medical students are frequently the 'guinea pigs' in this phase. Subsequently the drug is tested in people with the condition(s) for which it is intended. A significant statistical advantage is sought. Trials may end prematurely if the interim figures suggest a significant benefit or if significant harm is noted during the trial.
Problems arise when
1) the drug is not tested on the target population or an appropriate animal model (Thalidomide)
2) the drug has delayed effects occurring outside the life of the study (DES)
3) special interests interfere - the concept of 'catastrophic rights' giving rise to a demand that any drug that might have a beneficial effect be released prior to adequate testing on the grounds that since one is dying one has a right to try anything that may help.
And of course 4) Scientific cheating, which while hard to get away with, does occur.
Comments?
Dr Shakes
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